MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Electromagnetic Interference (1194); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was calling because they noticed they only get 0-2 coupling bars while charging their right implantable neurostimulator (ins).The poor coupling was stated to have been getting worse, charging was stated to be difficult on the right ins, while also "taking a long time." the patient stated they've been "seeming to have a hard time finding a place where the ins will take a charge," and noted it seemed to be "fleshier" over the ins on the right side, whereas the left they could feel the ins "very easily." the patient inquired if this could be the cause of the issues.Troubleshooting: the patient states they turned the antenna dial, but this did not resolve the poor coupling issue.They stated they "always" have the recharger antenna on their bare skin and hold it in place with their hand.They get zero coupling bars on both sides if the recharger antenna is over a shirt.While on ca ll, the patient started a charge session on the right side and reported getting 6 coupling bars initially, then 8, then 6.It was reviewed this is considered good coupling and the patient confirmed they understood.Due to the patient having experienced poor coupling for 2 months, it was offered to replace the antenna to rule out external equipment, and the patient was advised to follow-up with their healthcare provider (hcp) if the poor coupling were to persist after receiving the replacement.It was mentioned the antenna was replaced a couple months ago, as the cord was starting to get frayed.Additional information was received: it was reported that the patient called again expressing the same concerns and said the reason they called was to ask about if getting dental x-rays could¿ve interfered with the device.Information was reviewed and the patient was told to follow up with their hcp.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.When asked if the dental x-rays were confirmed to have caused the device issues, they stated the x-ray "had no effect." although requested, no information regarding the cause was provided.There was stated to still be issues with slow charging and they said they could not get "a full charge." the patient stated they had an appointment regarding the issue on 2020-02-12.No further information was provided.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9687268
• MDR Text Key: 178371672
• Report Number: 3004209178-2020-02906
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Date Device Manufactured: 09/25/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Age: 68 YR
• Patient Weight: 82